Home NDC 60760-865 Butalbital, Acetaminophen and Caffeine
Product NDC 60760-865
11-digit product format 607600865
Labeler code 60760
Product ID 60760-865_36229f4e-5921-2fcd-e063-6294a90af60d
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Butalbital, Acetaminophen and Caffeine
Dosage form TABLET
Route ORAL
Labeler ST. MARY'S MEDICAL PARK PHARMACY
Application ANDA040864
Marketing category ANDA
Marketing start 2022-06-29
Substance ACETAMINOPHEN; BUTALBITAL; CAFFEINE
Active strength 325; 50; 40 mg/1; mg/1; mg/1
Pharmacologic classes Barbiturate [EPC], Barbiturates [CS], Central Nervous System Stimulant [EPC], Central Nervous System Stimulation [PE], Methylxanthine [EPC], Xanthines [CS]
DEA schedule CIII
NDC exclude flag No
Listing certified through 2026-12-31
Current FDA listing Yes Additional Listing Data#
Finished product Yes
Brand name base Butalbital, Acetaminophen and Caffeine
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength ACETAMINOPHEN 325 mg/1 BUTALBITAL 50 mg/1 CAFFEINE 40 mg/1
Harmonized Identifiers# Field, Values table Field Values Unii 362O9ITL9D, KHS0AZ4JVK, 3G6A5W338E Rxcui 238154
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 60760-865-12 Butalbital, Acetaminophen and Caffeine 12 in 1 BOTTLE, PLASTIC TABLET 12 1
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 60760-865-12 60760086512 12 TABLET in 1 BOTTLE, PLASTIC (60760-865-12) 12 tablet 2025-05-19 No No Current